MICONAZOL

MICONAZOL acis Cream

Important notes (mandatory information)

Miconazole acis cream 20 mg/g. Active ingredient: Miconazole nitrate. Areas of application: for fungal infections of the skin, skin folds, spaces between fingers and toes, and superficial infections caused by yeast fungi.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Miconazole acis cream 20 mg/g
Active ingredient: Miconazole nitrate

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS MICONAZOLE ACIS CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING MICONAZOLE ACIS CREAM?
3. HOW TO USE MICONAZOLE ACIS CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MICONAZOLE ACIS CREAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MICONAZOLE ACIS CREAM AND WHAT IS IT USED FOR?

Miconazole acis cream is a fungicidal medicine for external treatment of fungal infections of the skin (antimycotic). Miconazole acis is used for fungal infections of the skin, skin folds, spaces between fingers and toes, and superficial infections caused by yeast fungi. Miconazole acis cream is used in infants, children and adults.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MICONAZOLE ACIS CREAM?

Miconazole acis cream must not be used if you are allergic to miconazole nitrate, related fungicidal medicines, benzoic acid 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 Miconazole acis cream. Miconazole acis cream is for external use only and must not be taken orally. Avoid contact with the eyes. If hypersensitivity reactions or irritation occur, treatment should be discontinued.

Note

In the case of treatment in the genital or anal area, the excipients contained (stearates and paraffin) may reduce the tear resistance of latex condoms and thus impair the safety of condoms.

Use of Miconazole acis cream together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Miconazole can inhibit the metabolism of medicines that are broken down via the liver (enzymes cytochrome-P450-2C9 and -3A4). Interactions are only to be expected in very rare cases after application to the skin.

The following medicines should be used with caution, as the effect and/or side effects may be increased or prolonged:

• anticoagulant medicines, e.g. warfarin (monitoring of blood coagulation values).
• certain medicines for the treatment of elevated blood sugar levels, e.g. sulfonylureas (monitoring of blood sugar levels).
• certain medicines for the treatment of epilepsy, e.g. phenytoin (monitoring of plasma levels).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Miconazole applied to the skin is absorbed by the body to a very small extent (less than 1%). There are no data on whether the active ingredient is excreted in breast milk. During pregnancy and breast-feeding, you should therefore only use Miconazole acis cream after consulting a doctor. Please do not use Miconazole acis cream in the breast area during breast-feeding. This will prevent the infant from coming into direct contact with Miconazole acis cream.

Driving and using machines

Miconazole acis cream has no or negligible influence on the ability to drive and use machines.

Miconazole acis cream contains benzoic acid

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

3. HOW TO USE MICONAZOLE ACIS CREAM?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage

Wash the affected skin areas thoroughly before each application and dry them carefully. Apply a small amount of cream to the affected skin and the surrounding skin area (approx. 1 to 2 cm) twice a day (preferably in the morning and evening). If powder and cream are used, it is recommended to use both dosage forms once a day.

Type of use

Massage the cream in with your finger until it has been absorbed. After using the cream, you should wash your hands thoroughly (exception: treatment of the hands).

Duration of use

The total treatment time is on average 2 to 6 weeks. The signs of the fungal infection usually recede significantly within the first 7 days after starting treatment with Miconazole acis cream. If the signs of the fungal infection do not recede within the first 7 days after starting treatment, you must consult a doctor. To prevent recurrence, treatment should be continued until the fungal culture is negative, but for at least one week after all symptoms have disappeared. There should be a treatment-free period of 3 - 4 days between the last application of Miconazole acis cream and the creation of a fungal culture so that any active ingredient residues do not influence the culture. Do not use Miconazole acis cream for longer than 7 days without medical advice.

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

If you have used more Miconazole acis cream than you should

Excessive use can lead to skin reactions, which usually recede after the end of therapy. If Miconazole acis cream is accidentally ingested, please contact your doctor.

If you forget to use Miconazole acis cream

Do not use double the dose to make up for the forgotten application.

If you stop using Miconazole acis cream

If you stop treatment with Miconazole acis cream too early, the fungal infection may recur.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very rare (may affect up to 1 in 10,000 people):

• Hypersensitivity reactions with itching and swelling and redness of the skin; also severe courses with shortness of breath and drop in blood pressure.
• Hives, contact eczema, rash, burning of the skin, skin inflammation.
• Skin irritation, sensation of warmth.
• Locally limited reduction in normal skin colour.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE MICONAZOLE ACIS CREAM?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the tube and the folding box. The expiry date refers to the last day of the month indicated. Do not store above 30°C.

Note on shelf life after opening

Miconazole acis cream can be stored for 3 months after opening.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Miconazole acis cream contains

The active ingredient is: Miconazole nitrate. 1 g cream contains 20 mg miconazole nitrate. The other ingredients are: Benzoic acid (E210), macrogol stearate 1500, macrogolglycerololeates (Ph.Eur.), liquid paraffin, purified water.

What Miconazole acis cream looks like and contents of the pack

Miconazole acis cream is a white cream. Miconazole acis cream is available in aluminium tubes with 20 g and 50 g cream. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

acis Arzneimittel GmbH
Lil-Dagover-Ring 7
82031 Grünwald
Phone: 089/4423246 0
Fax: 089/4423246 66
E-mail: info@acis.de

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna

This package leaflet was last revised in April 2020.

Source: Information from the package leaflet
Status: 11/2020
Active ingredient: Miconazole nitrate. Areas of application: for fungal infections of the skin, skin folds, spaces between fingers and toes, and superficial infections caused by yeast fungi.