LINOLA

LINOLA sept Antiseptic Skin Cream with Clioquinol

Important notes (mandatory information)

Linola sept Antiseptic Skin Cream with Clioquinol. Areas of application: for infected skin diseases.

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


PACKAGE LEAFLET: INFORMATION FOR USERS

Linola sept Antiseptic Skin Cream with Clioquinol
Active ingredient: 0.5 g clioquinol per 100 g cream

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 your doctor or pharmacist has told you.
• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice 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 LINOLA SEPT ANTISEPTIC SKIN CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING LINOLA SEPT ANTISEPTIC SKIN CREAM?
3. HOW TO USE LINOLA SEPT ANTISEPTIC SKIN CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE LINOLA SEPT ANTISEPTIC SKIN CREAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LINOLA SEPT ANTISEPTIC SKIN CREAM AND WHAT IS IT USED FOR?

Linola sept Antiseptic Skin Cream is an antiseptic cream for use on the skin. Linola sept Antiseptic Skin Cream is used for infected skin diseases.

2. WHAT SHOULD YOU CONSIDER BEFORE USING LINOLA SEPT ANTISEPTIC SKIN CREAM?

Linola sept Antiseptic Skin Cream must not be used:

• if you are allergic to clioquinol, its derivatives, methyl 4-hydroxybenzoate, sodium methyl 4-hydroxybenzoate or any of the other ingredients of this medicine listed in section 6.
• in case of iodine hypersensitivity.
• in the ear canal in case of otitis media, as damage to the inner ear cannot be ruled out if clioquinol enters the tympanic cavity.
• on the conjunctiva.
• during pregnancy and breastfeeding.

Warnings and precautions

Please talk to your doctor or pharmacist before using Linola sept Antiseptic Skin Cream. In patients with thyroid disorders, the iodine plasma level should be monitored during long-term use of Linola sept Antiseptic Skin Cream.

If Linola sept Antiseptic Skin Cream is used in the genital or anal area and latex products (e.g. condoms, diaphragms) are used at the same time, the functionality of these products may be reduced and thus their safety may be impaired due to the auxiliary substances contained (in particular stearates).

If clothing is placed directly on the creamed skin areas, yellow discolouration may occur. If the garments are washed out immediately, no permanent discolouration is to be expected, while dried-in stains can only be removed with difficulty or not at all. It is therefore advisable to cover the treated skin areas with, for example, gauze. However, cleaning the skin is easy.

Children

Linola sept Antiseptic Skin Cream should only be used on infants and toddlers after consulting a doctor and following their instructions.

Use of Linola sept Antiseptic Skin Cream together with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. No interactions are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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. Linola sept Antiseptic Skin Cream must not be used during pregnancy and breastfeeding.

3. HOW TO USE LINOLA SEPT ANTISEPTIC SKIN 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. Linola sept Antiseptic Skin Cream is a cream for use on the skin. Apply Linola sept Antiseptic Skin Cream thinly to the affected skin areas twice a day and then rub in the cream gently. Apply Linola sept Antiseptic Skin Cream until the skin condition improves or as directed by your doctor.

If you have used more Linola sept Antiseptic Skin Cream than you should

If Linola sept Antiseptic Skin Cream is used in too large a quantity or too often, side effects on the skin may be increased. In this case, it is sufficient to stop the treatment. The irritation will then quickly subside on its own.

If you forget to use Linola sept Antiseptic Skin Cream

Do not use twice the amount if you have forgotten the previous application. Continue treatment with the usual amount at the next application.

If you stop using Linola sept Antiseptic Skin Cream

Discuss the further procedure with your doctor or pharmacist, as otherwise the success of the treatment may be jeopardised.

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.

Rare (1 to 10 in 10000 treated persons)

Hypersensitivity reactions (e.g. allergic reactions).

Very rare (less than 1 in 10000 treated persons)

Reddish discolouration of white hair when Linola sept Antiseptic Skin Cream is used on the scalp, which disappears when the hair grows back. Methyl 4-hydroxybenzoate and sodium methyl 4-hydroxybenzoate may cause hypersensitivity reactions, including delayed reactions.

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 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 LINOLA SEPT ANTISEPTIC SKIN 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. This medicinal product does not require any special storage conditions. Shelf life after opening: 1 year. 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. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Linola sept Antiseptic Skin Cream contains
The active substance is clioquinol. 100 g cream contains 0.5 g clioquinol. The other ingredients are: Carbomer 980, Decyl oleate, Unsaturated fatty acids (C18), Glycerol monostearate, Macrogol stearyl ether (3) (Ph. Eur.), Methyl 4-hydroxybenzoate (Ph. Eur.) (E218), Sodium methyl 4-hydroxybenzoate (E215), Stearic acid (Ph. Eur.) (E570), Trometamol, Bleached wax, Purified water.

What Linola sept Antiseptic Skin Cream looks like and contents of the pack

Linola sept Antiseptic Skin Cream is a very slightly yellowish, thin cream in aluminium tubes. Linola sept Antiseptic Skin Cream is available in packs of 5 g, 15 g, 25 g, 50 g and 100 g cream. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstraße 56
33611 Bielefeld
Telephone: 0521 8808-05
Telefax: 0521 8808-334
E-mail: aw-info@drwolffgroup.com

This leaflet was last revised in April 2022.

Source: Package leaflet information
Status: 09/2024
Areas of application: for infected skin diseases.