INFECTOSOOR

INFECTOSOOR zinc ointment

Important notes (mandatory information)

InfectoSoor Zinc Ointment. Areas of application: is used to treat inflammation of the skin and skin folds that are affected by yeast (Candida spp.).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

InfectoSoor Zinc Ointment, 2.5 mg/g + 150 mg/g Ointment
Active ingredients: Miconazole nitrate and zinc oxide

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 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 package leaflet. See section 4.
• If you do not feel better or if you feel worse after 5 days, contact your doctor or pharmacist.

What this package leaflet contains

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

1. WHAT IS INFECTOSOOR ZINC OINTMENT AND WHAT IS IT USED FOR?

InfectoSoor Zinc Ointment is a broad-spectrum medicine for treating fungal skin infections. InfectoSoor Zinc Ointment is used to treat inflammation of the skin and skin folds that are affected by yeast (Candida spp.).

2. WHAT SHOULD YOU CONSIDER BEFORE USING INFECTOSOOR ZINC OINTMENT?

InfectoSoor Zinc Ointment must not be used if you are allergic to miconazole nitrate, related antifungal medications, zinc oxide 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 InfectoSoor Zinc Ointment. The ointment should not be used on open wounds. Avoid contact with the eyes. If hypersensitivity reactions or irritation occur, treatment should be discontinued.

Use of InfectoSoor Zinc Ointment together 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. InfectoSoor Zinc Ointment must not be mixed with other ointments or medicines. Miconazole, the active ingredient in InfectoSoor Zinc Ointment, can inhibit the breakdown of certain medicines. Interactions are unlikely after application of miconazole to the skin. Nevertheless, you should talk to your doctor or pharmacist before using InfectoSoor Zinc Ointment if you are taking the following medicines at the same time:

• Anticoagulants, e.g. phenprocoumon or warfarin
• Certain medicines to treat elevated blood sugar levels (sulfonylureas)
• Phenytoin (a medicine to treat epilepsy).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect 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 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. Therefore, you should only use InfectoSoor Zinc Ointment during pregnancy and breast-feeding after consulting your doctor. Please do not use InfectoSoor Zinc Ointment on the breast area while breast-feeding. This will prevent the infant from coming into direct contact with InfectoSoor Zinc Ointment.

Driving and using machines

No special precautions are required.

3. HOW TO USE INFECTOSOOR ZINC OINTMENT?

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 and method of administration

InfectoSoor Zinc Ointment is applied to the entire affected area at each change of aid (e.g. nappies, incontinence pads) and after each bath. Ointment for application to the skin. Unscrew the cap, place the cap upside down on the tube and pierce the seal with the tip. Before applying the ointment, the skin must be cleaned with lukewarm water and dried carefully. The ointment should be applied gently with your fingertips without massaging it in. Even when using the ointment, the usual measures for inflammation of the skin and skin folds should not be neglected: For example, highly occlusive, air- and moisture-impermeable nappies and incontinence aids should not be used and the aids should be changed frequently. The affected skin must not be cleaned with perfumed soaps, shampoos or lotions.

Duration of use

Treatment should be continued for at least one week after all symptoms have disappeared. If there is no improvement after 7 days, you should see your doctor.

If you have used more InfectoSoor Zinc Ointment than you should

Overdosage is not to be feared when applied to the skin. If you have accidentally taken (swallowed) the ointment, nausea, vomiting and diarrhoea may occur. Seek medical attention immediately.

If you forget to use InfectoSoor Zinc Ointment

Apply a missed application as soon as possible and then continue treatment as usual.

If you stop using InfectoSoor Zinc Ointment

Do not stop treatment too early. Otherwise, the infection may still be present and may possibly break out again.

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
• Skin irritation, sensation of warmth, burning of the skin
• Locally limited reduction in normal skin colour.

Occasionally (may affect up to 1 in 100 people):

• Skin irritation.

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 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 INFECTOSOOR ZINC OINTMENT?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box after "Use by" and on the tube fold. The expiry date refers to the last day of the month indicated. InfectoSoor Zinc Ointment should be stored at room temperature.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What InfectoSoor Zinc Ointment contains

The active ingredients are miconazole nitrate and zinc oxide. 1 g of ointment contains 2.5 mg of miconazole nitrate and 150 mg of zinc oxide. The other ingredients are: White petrolatum, glycerol tris(12-hydroxyoctadecanoate).

What InfectoSoor Zinc Ointment looks like and contents of the pack

InfectoSoor Zinc Ointment is a white ointment and is available in packs of 15 g, 2 x 15 g, 30 g, 2 x 30 g and 60 g. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Infectopharm Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
www.infectopharm.com

This leaflet was last revised in September 2015.

Source: Information from the package leaflet
Status: 11/2016
Areas of application: is used to treat inflammation of the skin and skin folds that are affected by yeast (Candida spp.).