Micotar cream, 50 g

Area of application

Micotar Cream is an antifungal medicine that is used for the external treatment of fungal skin diseases.It is effective against fungal infections of the skin, skin folds, between the fingers and toes as well as superficial infections caused by yeast fungi.The cream is suitable for use on infants, children and adults.

Active ingredients / ingredients / ingredients

Micotar Cream contains the active ingredient miconazole nitrate.One gram of the cream contains 20 milligrams of miconazole nitrate.The cream also contains the following other ingredients: benzoic acid (E210), macrogol stearate 1500, macrogol glycerol oleate (Ph. Eur.), thick paraffin and purified water.

Contraindications

Micotar cream should not be used if there is a known hypersensitivity to any of the ingredients mentioned.

Dosage

Before each use, the affected skin areas should be washed thoroughly and dried carefully.The cream is applied twice a day, preferably in the morning and evening, to the diseased skin and the surrounding skin area (approx. 1 to 2 cm).The total treatment time is on average 2 to 6 weeks.The signs of the fungal infection usually disappear significantly within the first 7 days after starting treatment with miconazole.If the symptoms do not go away within this time, a doctor should be consulted.To prevent recurrence, treatment should be continued until the fungal culture is negative, but at least one week after all symptoms have disappeared.There should be a treatment-free period of 3 to 4 days between the last application and the creation of a fungal culture.

Intake

The cream should be massaged in with your finger until it is absorbed.After using the cream, hands should be washed thoroughly, except when treating hands.

Patient information

Micotar Cream is for external use only and must not be taken.Contact with eyes should be avoided.In the event of hypersensitivity reactions or irritation, treatment should be discontinued.If latex condoms are used at the same time, their tear resistance may be reduced.The preparation has no or negligible influence on the ability to drive and use machines.

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.Miconazole applied to the skin is absorbed into the body to a very small extent (less than 1%).If you are pregnant or breastfeeding, you should only use miconazole after consulting a doctor.During breastfeeding, the cream should not be used on the breast area to avoid direct contact of the infant with the cream.

Notes

Do not get into eyes, mucous membranes or open wounds.No prescription is required for this product.

Address of the provider/manufacturer

DERMAPHARM AG
Lil Dagover Ring 7
82031 Grünwald

Important information (mandatory information)

Micotar cream 20 mg/g.Active ingredient: miconazole nitrate.Areas of application: Fungal infections of the skin caused by dermatophytes, yeasts, molds, etc., e.g. mycoses of the feet, mycoses of the skin and skin folds, superficial candidiasis.Used in infants, children and adults.Warning: Contains benzoic acid.

INSTRUCTIONS FOR USE: INFORMATION FÜR DEN ANWENDER

Micotar cream 20 mg/g, for use in infants, children and adults
Active ingredient: miconazole nitrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist tells you.

Keep the package leaflet.You may want to read these again later.Ask your pharmacist if you need further information or advice.If you notice any side effects, contact your doctor or pharmacist.This also applies to side effects that are not listed in this leaflet.If you or your child do not feel better or feel worse after 7 days, contact your doctor.

What is in this leaflet:
1. WAS IST MICOTAR CREME UND WOFÜR WIRD SIE APPLIED?
2. WAS MÜSSEN SIE VOR DER ANWENDUNG VON MICOTAR CREME NOTE?
3. WIE IST MICOTAR CREME TO APPLY?
4. WELCHE NEBENWIRKUNGEN SIND POSSIBLE?
5. WIE IST MICOTAR CREME TO KEEP?
6. INHALT DER PACKUNG UND WEITERE INFORMATION.

1. WAS IST MICOTAR CREME UND WOFÜR WIRD SIE APPLIED?
Micotar cream is an antifungal agent. Micotar Cream is used for interdigital mycoses (fungal infections between the toes), fungal diseases of the skin and skin folds and superficial candidiasis (yeast infections).Micotar cream is used for infants, children and adults.

2. WAS SOLLTEN SIE VOR DER ANWENDUNG VON MICOTAR CREME NOTE?
Micotar cream must not be used if you or the child being treated are allergic to miconazole nitrate, related antifungal medications or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions:
Please talk to your doctor or pharmacist before using Micotar cream.Micotar Cream is for external use only and must not be taken.Avoid contact with eyes.

Application of Micotar cream with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Miconazole can inhibit the metabolism of drugs that are broken down by the liver (cytochrome P450-2C9 and -3A4 enzymes).After application to the skin, interactions are only to be expected in very rare cases.

The following medicines should be used with caution as the effect and/or side effects may be increased or prolonged:
Anticoagulant medicines, e.g.B. Warfarin (monitoring blood clotting levels).
Certain medicines used to treat high blood sugar levels, e.g.B. Sulfonylureas (monitoring blood sugar levels).
Certain medicines used to treat epilepsy, e.g.B. Phenytoin (monitoring plasma levels).

Pregnancy and breastfeeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.Miconazole applied to the skin is absorbed into the body to a very small extent (less than 1%).There are no data available as to whether the active ingredient is excreted in breast milk.If you are pregnant or breastfeeding, you should only use Micotar Cream after consulting a doctor.To avoid direct contact of the infant with Micotar cream, breastfeeding women should not use the cream on the breast area during the entire breastfeeding period.

Ability to drive and use machines:
Micotar Cream has no or negligible influence on the ability to drive and use machines.

Micotar cream contains benzoic acid:
This medicine contains 2 mg of benzoic acid per 1 g of cream.Benzoic acid can cause local irritation.Benzoic acid can increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

When treating the genital or anal area, due to the other ingredients contained (stearates and paraffin) and the simultaneous use of latex condoms, the tear resistance may be reduced and the safety of the condoms may be impaired.

3. WIE IST MICOTAR CREME TO APPLY?
Always use this medicine exactly as described in this leaflet or exactly as discussed with your doctor or pharmacist.Ask your doctor or pharmacist if you are not sure.

The recommended dose is:
Apply the cream to the affected areas twice a day.Massage the cream into the skin with your finger until it is completely absorbed.The duration of application is 2 to 6 weeks, depending on the severity and location of the infection.If the signs of the fungal infection do not go away within the first 7 days after starting treatment, you must consult a doctor.Treatment should be continued for at least a week until all complaints and symptoms have disappeared.There should be a treatment-free interval of 3 to 4 days between the last application and the creation of a fungal culture so that any active ingredient residues do not disrupt the culture.

Please talk to your doctor or pharmacist if you have the impression that the effect of Micotar cream is too strong or too weak.

If you use more Micotar Cream than you should:
Excessive use may cause skin reactions, which usually resolve after therapy is stopped.If you accidentally ingest Micotar cream, please contact your doctor.

If you forget to use Micotar cream:
Do not make up for a forgotten treatment, but continue the therapy as usual.

If you stop using Micotar Cream:
Treatment should be carried out until the end, even if the symptoms have already disappeared.The infection may still persist and may flare up again if the medication is stopped too soon.

If you have any further questions about using this medicine, talk to your doctor or pharmacist.

4. WELCHE NEBENWIRKUNGEN SIND POSSIBLE?
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Possible side effects:
Very rare (may affect up to 1 in 10,000 people):
Hypersensitivity reactions with itching as well as swelling and redness of the skin, also severe cases with shortness of breath and drop in blood pressure, hives, contact eczema, skin rash, burning of the skin, skin inflammation, skin irritation, sensation of warmth, localized reduction in normal skin color.

Reporting side effects:
If you notice any side effects, contact your doctor or pharmacist.This also applies to side effects that are not listed in this leaflet.

5. WIE IST MICOTAR CREME TO BE KEPT?
Keep this medicine out of the reach and reach of children.

You must not use this medicine after the expiry date which is stated on the tube and carton after “use by”.The expiry date refers to the last day of the specified month.Do not store above 25°C.After opening the tube for the first time, Micotar Cream has a shelf life of 12 weeks.

Never throw away medicines via wastewater (e.g. not down the toilet or sink).Ask your pharmacy how to throw away medicine when you no longer use it.In doing so, you contribute to protecting the environment.

6. INHALT DER PACKUNG UND WEITERE INFORMATION.
What Micotar Cream contains:
The active ingredient is miconazole nitrate.1 g of cream contains 20 mg of miconazole nitrate.

The other components are:
Benzoic acid (E210), macrogol stearate 1500, macrogol glycerol oleate (Ph. Eur.), thick paraffin, purified water.

What Micotar cream looks like and contents of the pack:
Micotar Cream is a white cream and is available in tubes of 20g and 50g.

Pharmaceutical entrepreneur:
Dermapharm AG
Lil Dagover Ring 7
82031 Grünwald
Telephone: 089/641860
Fax: 089/64186130
Email: [email protected]

Manufacturer:
mibe GmbH pharmaceuticals
Münchener Straße 15
06796 Brehna
Telephone: 034954/247-0
Fax: 034954/247-100
(a subsidiary of Dermapharm AG)

This leaflet was last revised in April 2020.

Source: Information in the package insert
As of: 12/2024