SELERGO

SELERGO 1% Cream

Important notes (mandatory information)

Selergo 1% cream. Active ingredient: Ciclopirox-olamine. Areas of application: for the treatment of fungal skin infections.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Selergo 1% cream for use in adults and school children
Active ingredient: Ciclopirox-olamine

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 want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen or do not improve after 14 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS SELERGO 1% CREAM AND WHAT IS IT USED FOR?

Selergo 1% cream is a broad-spectrum antifungal agent. The active ingredient ciclopirox-olamine has a fungicidal effect on most fungi responsible for skin and mucous membrane infections. Selergo 1% cream is used to treat fungal skin infections.

2. WHAT SHOULD YOU CONSIDER BEFORE USING SELERGO 1% CREAM?

Selergo 1% cream must not be used if you are hypersensitive (allergic) to ciclopirox-olamine or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Selergo 1% cream is not suitable for use on the eye. If Selergo 1% cream is used in the genital or anal area, the use of latex condoms at the same time may reduce the tear resistance and thus impair the safety of such condoms due to the excipient "liquid paraffin".

Use of Selergo 1%

cream together with other medicines

Interactions with other agents are not known. Inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking/using any medicine. Ciclopirox-olamine can pass into breast milk in nursing mothers. For this reason, Selergo 1% cream must not be applied to the breast area under any circumstances. It is therefore not recommended to use it during breast-feeding.

Driving and using machines

No impairment is to be expected with short-term use of Selergo 1% cream.

Selergo 1%

cream contains cetyl alcohol and stearyl alcohol

Cetyl alcohol and stearyl alcohol can cause local skin irritation, e.g. contact dermatitis (inflammation of the skin).

3. HOW TO USE SELERGO 1% 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.

Adults and school children

Unless otherwise prescribed by your doctor, apply Selergo 1% cream to the affected areas twice a day. Rub in the cream gently and allow it to air dry. It is best to apply it after washing, showering or bathing. This way, the cream is not immediately removed by cleaning and can take effect for a sufficiently long time. Continue treatment with Selergo 1% cream until the skin symptoms subside (generally 2 weeks). To avoid relapses, it is recommended to continue treatment for another 1 - 2 weeks. Please talk to your doctor or pharmacist if you have the impression that the effect of Selergo 1% cream is too strong or too weak.

Children under 6 years of age

Since there is insufficient experience with the use of Selergo 1% cream in children under 6 years of age, the use of this medicine is not recommended in this age group.

If you have used more Selergo 1%

cream than you should

No cases of overdose have been reported to date.

If you forget to use Selergo 1%

cream

Continue treatment without applying Selergo 1% cream an additional time or applying a larger amount than usual. If you have not used the cream for several days, the effect may be impaired.

If you stop using Selergo 1%

cream

If you stop treatment with Selergo 1% cream prematurely, there is a risk that the fungal infection will start 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.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Skin and subcutaneous tissue disorders

Rare:

• Itching and mild burning. These symptoms can also be signs of a hypersensitivity reaction.
• Contact dermatitis (inflammation of the skin).

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 provide more information on the safety of this medicine.

5. HOW TO STORE SELERGO 1% 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 tube after "Use by". The expiry date refers to the last day of the month indicated. Store in the original package. Selergo 1% cream can be used for a further 3 months after first opening the tube. Do not dispose of medicines in wastewater or household waste (regional differences). Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Selergo 1%

cream contains

The active ingredient is ciclopirox-olamine. 1 g Selergo 1% cream contains 10 mg ciclopirox-olamine. The other ingredients are: Liquid paraffin, white petrolatum, polysorbate 60, N,N-bis(2-hydroxyethyl)coco fatty acid amide, octyldodecanol (Ph. Eur.), benzyl alcohol, sorbitan stearate, tetradecan-1-ol, cetyl alcohol (Ph. Eur.), stearyl alcohol (Ph. Eur.), lactic acid, purified water.

What Selergo 1% cream looks like and contents of the pack

Selergo 1% cream is a white to off-white homogeneous cream.

Selergo 1% cream is available in packs of 20 g or 40 g.

Marketing Authorisation Holder

Polichem S.A.
50, Val Fleuri
1526 Luxembourg Luxembourg

Co-distributor

Almirall Hermal GmbH
Geschäftsbereich Taurus Pharma
Scholtzstraße 3
21465 Reinbek
Phone: 040/72704-0
Fax: 040/7229296
info@almirall.de

Manufacturer

Alfa Wassermann S.p.A.
Via Enrico Fermi n° 1
65020 Alanno(PE)
Italy

This leaflet was last revised in January 2017.

Source: Package information
Version: 02/2018
Active ingredient: Ciclopirox-olamine. Areas of application: for the treatment of fungal skin infections.