MYKOSERT

MYKOSERT cream for skin and athlete's foot

Important notes (mandatory information)

Mykosert Cream for skin and foot fungus. Active ingredient: Sertaconazole nitrate. Areas of application: for external treatment of fungal infections of the skin caused by dermatophytes (e.g. athlete's foot) or yeasts (e.g. pityriasis versicolor).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Mykosert Cream for skin and foot fungus
Active ingredient: Sertaconazole 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 leaflet or exactly as directed by your doctor or pharmacist.
• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.

What this leaflet contains

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

1. WHAT IS MYKOSERT CREAM AND WHAT IS IT USED FOR?
Mykosert Cream is a local broad-spectrum antifungal agent from the imidazole group. Mykosert Cream is used for the external treatment of fungal infections of the skin caused by dermatophytes (e.g. athlete's foot) or yeasts (e.g. pityriasis versicolor).

2. WHAT SHOULD YOU CONSIDER BEFORE USING MYKOSERT CREAM?

Mykosert Cream must not be used if you are allergic to sertaconazole nitrate, methyl 4-hydroxybenzoate or any of the other ingredients of this medicine listed in section 6.

Using Mykosert Cream with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. Interactions are not known to date. If latex products (e.g. condoms, diaphragms) are used at the same time, the functional capacity may be reduced and thus the safety of these products may be impaired due to the excipients (stearates, paraffin) contained.

Pregnancy, breast-feeding and fertility

There is no clinical experience with use during pregnancy and breast-feeding. To avoid contact with the infant, Mykosert Cream must not be used in the breast area during breast-feeding.

Driving and using machines

No impairments are known.

Mykosert Cream contains methyl 4-hydroxybenzoate

Methyl 4-hydroxybenzoate can cause hypersensitivity reactions, also with a time delay. Sorbic acid can cause local skin irritation (e.g. contact dermatitis).

3. HOW TO USE MYKOSERT CREAM?

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

Unless otherwise prescribed by your doctor, Mykosert Cream is applied to the affected skin areas as follows

For skin infections with yeasts and dermatophytes, such as tinea pedis (athlete's foot) 1 - 2 times daily (at intervals of 12 hours).

Duration of use

Treatment is continued until complete healing, for a maximum of 28 days. As a rule, the symptoms improve after a few days. However, continue the treatment as recommended. If treatment is not carried out regularly or is stopped prematurely, the symptoms may recur.

If you do not notice an improvement in your symptoms within two weeks of starting treatment, please contact your doctor.

If you have used more Mykosert Cream than you should

Poisoning and overdose symptoms are not known.

If you forget to use Mykosert Cream

If you forget to use it once, continue using it as described in the dosage instructions or as prescribed by your doctor.

If you stop using Mykosert Cream

Premature discontinuation of treatment may impair the healing success.

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

Skin irritation such as redness, burning and itching.

Contact allergic reactions are possible when using Mykosert Cream, which can manifest themselves as itching, redness, blisters also beyond the contact area (so-called scattered reactions). Methyl 4-hydroxybenzoate can cause hypersensitivity reactions, also with a time delay.

Reporting of side effects

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

5. HOW TO STORE MYKOSERT CREAM?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container. The expiry date refers to the last day of the month. Do not store above 30°C. Do not dispose of medicines in wastewater (via toilet or sink). Any unused medicine can be disposed of in household waste. This helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mykosert Cream contains

The active ingredient is sertaconazole nitrate. 1 g cream contains 20 mg sertaconazole nitrate. The other ingredients are: methyl 4-hydroxybenzoate (Ph.Eur.) (E218), sorbic acid (Ph.Eur.) (E200), mixture of glycerol monoisostearate/glycerol diisostearate, macrogol-1500-(mono, di)stearate, macrogol-6-glycerol(mono, di)alkanoate (C12-C18), liquid paraffin, purified water.

What Mykosert Cream looks like and contents of the pack

White, semi-solid cream with a liquid consistency. Odourless or with a slightly oily odour; packs of 20 g and 50 g cream. For production reasons, the tube is filled to a quarter with air. The specified filling quantity of each tube is automatically checked during production.

Pharmaceutical entrepreneur and manufacturer

Dr. Pfleger Arzneimittel GmbH
D-96045 Bamberg
Phone: 0951/6043-0
Fax: 0951/604329
E-mail: info@dr-pfleger.de

This leaflet was last revised in November 2019.

Source: Package leaflet information
Status: 01/2022
Active ingredient: Sertaconazole nitrate. Areas of application: for external treatment of fungal infections of the skin caused by dermatophytes (e.g. athlete's foot) or yeasts (e.g. pityriasis versicolor).