LINOLA

LINOLA fat cream

Important notes (mandatory information)

Linola Fett. Active ingredient: unsaturated fatty acids. Areas of application: for supportive use in mild to moderate forms of atopic eczema (neurodermatitis) in the subacute to chronic stage.

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


Patient information: Information for the user

Linola Fett
Active ingredient: 0.815 g unsaturated fatty acids (C18:2 fatty acids) 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 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, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

What this package leaflet contains

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

1. WHAT IS LINOLA FETT AND WHAT IS IT USED FOR?

Linola Fett is a cream for the treatment of skin conditions on dry skin. Linola Fett is used for supportive use in mild to moderate forms of atopic eczema (neurodermatitis) in the subacute to chronic stage.

2. WHAT SHOULD YOU CONSIDER BEFORE USING LINOLA FETT?

Linola Fett must not be used if you are allergic to unsaturated fatty acids, peanuts or soya 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 Linola Fett. If Linola Fett is used at the same time in the genital or anal area and latex products (e.g. condoms, diaphragms), the functional capacity of these products may be reduced and thus their safety may be impaired due to the excipients contained (in particular paraffin, petroleum jelly and stearates).

Caution: The can may have a sharp edge after opening. If necessary, use a removal aid.

Use of Linola Fett 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 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. Linola Fett can be used during pregnancy and breast-feeding. If you are breast-feeding, you should not use Linola Fett in the breast area so that the breast-fed newborn/infant does not ingest any cream ingredients with the breast milk.

Linola Fett contains wool wax, cetyl stearyl alcohol and butylhydroxytoluene

Wool wax can cause localised skin irritation (e.g. contact dermatitis). Cetyl stearyl alcohol can cause localised skin irritation (e.g. contact dermatitis). Butylhydroxytoluene can cause localised skin irritation (e.g. contact dermatitis), irritation of the eyes and mucous membranes.

3. HOW TO USE LINOLA FETT?

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. Linola Fett is a cream for application to the skin. Apply Linola Fett evenly to dry skin several times a day. In general, twice-daily application is sufficient. Use Linola Fett until the skin condition improves or as directed by your doctor. The tolerability of Linola Fett has been demonstrated for a period of up to 4 weeks.

Use in children and adolescents

The same dosage recommendations apply to children and adolescents as to adults.

If you have used more Linola Fett than you should

It is not a problem if too much cream is applied. Simply wipe off the excess.

If you forget to use Linola Fett

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

If you stop using Linola Fett

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.

Common (1 to 10 out of 100 treated)

Localised skin reactions (e.g. contact dermatitis) with redness and burning or itching.

Not known (frequency cannot be estimated from the available data)

Mild skin swelling. Peanut oil can rarely cause severe allergic 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 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, 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 FETT?

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. Do not store above 30 °C. Shelf life after opening: 1 year. Do not use this medicine if the appearance of the cream has changed significantly. However, occasional oil separation or structuring does not affect the efficacy of Linola Fett. Do not dispose of medicines in wastewater or household waste. 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 Linola Fett contains
The active ingredient is: 0.815 g unsaturated fatty acids (C18:2 fatty acids) per 100 g cream (type W/O emulsion).
The other ingredients are: Aluminium stearate, beta-carotene (E160a), butylhydroxytoluene (Ph. Eur.) (E321), cetyl stearyl alcohol (Ph. Eur.) [vegetable], decyl oleate, refined and hydrogenated peanut oil, hard fat, hard paraffin, aliphatic hydrocarbons (C40-C60), magnesium stearate (Ph. Eur.) [vegetable] (E572), thick liquid paraffin, sorbitan stearate (E491), sunflower oil, white petroleum jelly, bleached wax, purified water, wool wax, wool wax alcohols, 2-(4-tert-butylbenzyl)propanal.

What Linola Fett looks like and contents of the pack

Linola Fett is an easily spreadable, whitish cream in an aluminium tube or a can. Linola Fett is available in packs of 15 g, 25 g, 50 g, 75 g, 100 g, 150 g, 250 g, 700 g, 20 x 15 g and 2 x 250 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: info@wolff-arzneimittel.de

This leaflet was last revised in April 2016.

Source: Package leaflet information
Status: 11/2017
Active ingredient: unsaturated fatty acids. Areas of application: for supportive use in mild to moderate forms of atopic eczema (neurodermatitis) in the subacute to chronic stage.