Linola

Leaflet attached to the packaging: patient information

Linola 0.815 g/100 g ointment

Unsaturated fatty acids

Please read the contents of the leaflet carefully before using the medicine, as it contains

important information for the patient.
The medicine should always be used exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Linola ointment and what is it used for
• 2. Important information before using Linola ointment
• 3. How to use Linola ointment
• 4. Possible side effects
• 5. How to store Linola ointment
• 6. Package contents and other information

1. What is Linola ointment and what is it used for

The medicine contains the active substance - unsaturated fatty acids, which, when applied to the skin,
act locally anti-inflammatory.

Indications:

Supportively in the treatment of mild and moderately severe forms of atopic dermatitis (neurodermatitis) in the subacute to chronic phase.

2. Important information before using Linola ointment

When not to use Linola ointment:

Warnings and precautions

Before starting to use Linola ointment, the patient should discuss it with their doctor or pharmacist.
The tensile strength and effectiveness of condoms are reduced when the medicine is used in the anal and genital areas.

Linola ointment and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
During breastfeeding, the medicine should not be used in the breast area, due to the risk of the baby ingesting the medicine while breastfeeding.

Driving and operating machinery

No effects of the medicine on the ability to drive vehicles or operate machinery have been observed.

What Linola ointment contains:

• cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis),
• anhydrous lanolin (butylhydroxytoluene) and may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation,
• arachidic oil (from peanuts). If the patient is allergic to peanuts or soy, they should not use this medicine.

3. How to use Linola ointment

This medicine should always be used exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for use on the skin.
The medicine should be applied evenly to the skin, usually several times a day, depending on the need.
It is usually sufficient to use the medicine twice a day.
Duration of use:
The medicine is used until the skin condition improves and (or) according to the doctor's instructions.
It has been shown that the medicine is usually well tolerated when used for up to 4 weeks.

Using a higher dose of Linola ointment than recommended

In the event of using a higher dose of the medicine than recommended, treatment should be continued according to the recommended dosage and method of use.

Missing a dose of Linola ointment

A double dose should not be used to make up for a missed dose.

Stopping the use of Linola ointment

The patient should consult their doctor regarding further action if the treatment is at risk of being disrupted.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should consult their doctor or pharmacist.
In rare cases (in less than 1 in 1000, but more than 1 in 10,000 treated patients)
the arachidic oil contained in the medicine may cause local skin reactions (e.g., contact dermatitis) or severe allergic reactions.
Common side effects (in less than 1 in 10, but more than 1 in 100 patients) are
local skin reactions (e.g., contact dermatitis) with redness and itching or skin pruritus.
A side effect whose frequency cannot be established based on available data is skin edema.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
{current address ,phone and fax number of the aforementioned Department} e-mail: adr@urpl.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Linola ointment

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the box and (or) tube.
Store in the original packaging at a temperature below 30°C. Do not freeze.
Shelf life after first opening the packaging – 12 months.
The expiry date means the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Linola ointment contains

• The active substances of the medicine are unsaturated fatty acids.
• The other excipients are: white wax, hardened fat, sorbitan monostearate, cetostearyl alcohol, hardened arachidic oil, refined arachidic oil, lanolin alcohols, liquid paraffin, solid paraffin, decyl oleate (liquid wax), beta-carotene 30% (E 160), 2-(4-tert-butylbenzyl) propionaldehyde, purified water, permulgin, including: micro-wax, magnesium stearate, solid paraffin, aluminum stearate, anhydrous lanolin.

What Linola ointment looks like and what the packaging contains

Linola ointment is a skin ointment. The packaging contains a tube (50 g, 75 g, 100 g, 150 g, 250 g) or a tin (700 g) and a leaflet.

Responsible entity and manufacturer:

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstraße 56
33611 Bielefeld, Germany
Phone: + 49 521 8808-05
Fax: + 49 521 8808-334
To obtain more detailed information, the patient should contact the representative of the responsible entity:
Solpharm Sp. z o.o.
ul. Zwycięzców 42/93
03-938 Warsaw
Phone: +48 /22/ 616 28 08
Email: biuro@solpharm.pl
www.solpharm.pl

Date of the last update of the leaflet: