Essentiale Max

Leaflet attached to the packaging: patient information

Essentiale MAX, 600 mg, hard capsules

Phospholipidum essentiale

Please read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, please contact a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Essentiale Max and what is it used for
• 2. Important information before taking Essentiale Max
• 3. How to take Essentiale Max
• 4. Possible side effects
• 5. How to store Essentiale Max
• 6. Package contents and other information

1. What is Essentiale Max and what is it used for

Essentiale Max is a plant-based medicine used in liver diseases.

Indications for use

It reduces subjective patient complaints such as: loss of appetite, feeling of pressure in the right upper abdomen caused by liver damage due to an improper diet, toxic substances, or in the course of hepatitis.

2. Important information before taking Essentiale Max

When not to take Essentiale Max

• if the patient is allergic to the active substance, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Essentiale Max, the patient should discuss it with their doctor or pharmacist.

• Taking Essentiale Max cannot replace the exclusion of harmful substances from the diet that cause liver damage (e.g., alcohol),
• In chronic hepatitis, the use of supportive treatment with Essentiale Max is justified only when the patient feels an improvement in their overall well-being during treatment.

If there is no improvement after 7 days, the patient feels worse, symptoms have worsened, or other non-specific symptoms have occurred, they should contact their doctor.
Children and adolescents
There is insufficient data on the use of Essentiale Max in children.
Therefore, Essentiale Max should not be used in children under 12 years of age.

Essentiale Max and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Before taking Essentiale Max with anticoagulant agents, the patient should consult their doctor.

Essentiale Max with food and drink

Capsules should be taken during meals, without chewing (washing down, e.g., with a glass of water).

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 taking this medicine.
Soybeans are often a food ingredient, and so far, no harmful effect on the course of pregnancy has been observed during their use. However, sufficient studies have not been conducted.
Therefore, the use of this medicine during pregnancy and breastfeeding is not recommended.

Driving and using machines

Essentiale Max has no effect on driving and using machines.

Essentiale Max contains soybean oil, ethanol, and sodium

Due to the presence of soybean oil, the medicine may rarely cause severe allergic reactions. It should not be used in case of known hypersensitivity to peanuts or soy.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered "sodium-free".
This medicine contains 20 mg of alcohol (ethanol) in each capsule, equivalent to 21.28 mg/g (2.13% w/w). The amount of ethanol in one capsule is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.

3. How to take Essentiale Max

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
Unless otherwise directed by a doctor, the following dose is usually taken:
Adults and children over 12 years:1 capsule 3 times a day.
Capsules should be taken during meals, without chewing (washing down, e.g., with a glass of water).
Essentially, there are no time limits for taking Essentiale Max, but the recommended treatment duration should be at least 1-3 months.
The duration of treatment may also be determined individually by a doctor.

Use in children and adolescents

There is insufficient data on the use of Essentiale Max in children under 12 years of age. Therefore, Essentiale Max should not be used in children under 12 years of age.

Taking a higher dose of Essentiale Max than recommended

Taking a higher dose of the medicine than recommended may cause an increase in the described side effects.
There have been no reported cases of Essentiale Max overdose so far.

Missing a dose of Essentiale Max

In case of missing a dose, the patient should take it as soon as possible, unless it is close to the time of the next dose. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about taking 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.
Frequency not known(frequency cannot be estimated from the available data):
an allergic reaction may occur, such as rash, urticaria, itching, gastrointestinal disorders, e.g., nausea, vomiting, diarrhea, abdominal discomfort; increased blood pressure, palpitations, dizziness.

Reporting side effects

If any side effects occur, including any 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
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Essentiale Max

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified 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 Essentiale Max contains

• Active substance: phospholipids from soybeans containing: (3-sn-phosphatidyl)choline. One capsule contains 600 mg.
• Other ingredients are: hardened fat (Witepsol W 35), purified soybean oil, α-tocopherol, hydrogenated castor oil, hardened fat (Witepsol S 55), 96% ethanol, ethyl vanillin, 4-methoxyacetophenone.

Coating: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), black iron oxide (E 172),
red iron oxide (E 172).

What Essentiale Max looks like and what the package contains

Yellow to brown paste with a honey-like consistency in a brown, opaque, elongated hard capsule. The package contains 30, 42, or 90 brown capsules in PVC/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
{Sanofi logo}
Manufacturer
A.Nattermann & Cie. GmbH
Nattermannallee 1
D-50829 Cologne
Germany
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52
35-233 Rzeszów
To obtain more detailed information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
phone: +48 22 280 00 00

Date of last revision of the leaflet: April 2025