Essentiale forte

Package Leaflet: Information for the Patient

Essentiale Forte, 300 mg, Capsules

Phospholipidum essentiale

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Essentiale Forte and what is it used for
• 2. Important information before taking Essentiale Forte
• 3. How to take Essentiale Forte
• 4. Possible side effects
• 5. How to store Essentiale Forte
• 6. Contents of the pack and other information

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

Essentiale Forte is a plant-based medication used in liver diseases.
It contains essential phospholipids (Phospholipidum essentiale)that are glyceryl esters of choline phosphoric acid and unsaturated fatty acids: linoleic, linolenic, and oleic.
These phospholipids, due to their content of polyunsaturated fatty acids in the side chains, cannot be synthesized in the body.
The phospholipids contained in Essentiale Forte, after entering the liver, are incorporated into the membranes of liver cells. This leads to the replenishment of existing deficiencies resulting from the disease process and faster regeneration of damaged liver cells.
Phospholipids are essential in the process of differentiation and proliferation of liver cells.
They inhibit fibrosis processes in the liver by reducing collagen production and increasing the activity of the enzyme that breaks it down - collagenase.
The phospholipids incorporated into the membranes of liver cells reduce the sensitivity of these cells to factors of the immune system that may damage them.
Phospholipids are secreted into bile, where they reduce the cholesterol/phospholipid ratio and increase the solubility of cholesterol in it - thanks to the emulsifying properties of essential phospholipids, this has great importance in the prevention of gallstones.
Phospholipids, along with bile acids, play an important role in fat digestion and the absorption of fat-soluble vitamins.
Additionally, the polyunsaturated fatty acids that make up the phospholipids reduce cholesterol levels and normalize lipoprotein levels in serum - showing a beneficial anti-atherosclerotic effect. They also increase the transport of cholesterol from extrahepatic tissues to the liver and activate lipolytic enzymes. Polyunsaturated fatty acids improve blood flow in vessels by reducing platelet adhesion and increasing the elasticity of red blood cells.

Indications for Use

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, the action of toxic substances, or in the course of hepatitis.

2. Important Information Before Taking Essentiale Forte

When Not to Take Essentiale Forte

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

Warnings and Precautions

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

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

If after 7 days there is no improvement, the patient feels worse, symptoms have worsened, or other non-specific symptoms have appeared, they should consult their doctor.

Children and Adolescents

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

Essentiale Forte and Other Medications

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

Essentiale Forte 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 medication.
Soybeans are often a component of food, and so far, no harmful effect on the course of pregnancy has been observed during their use. However, sufficient studies have not been conducted. In connection with the above, the use of this medication during pregnancy and breastfeeding is not recommended.

Driving and Operating Machinery

Essentiale Forte does not affect the ability to drive or operate machinery.

Essentiale Forte Contains Soybean Oil, Ethanol, and Sodium

Due to the content of soybean oil, the medication may cause severe allergic reactions.
Do not use in case of known hypersensitivity to peanuts or soy.
This medication contains less than 1 mmol of sodium (23 mg) per dose, which means it is considered "sodium-free".
This medication contains 10 mg of alcohol (ethanol) in each capsule, which is equivalent to 20.49 mg/g (2.05% 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 medication will not cause noticeable effects.

3. How to Take Essentiale Forte

This medication should always be taken exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
Adults and children over 12 years: 2 capsules 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 the use of Essentiale Forte, but the recommended treatment duration should be at least 1-3 months.
The duration of treatment may also be determined individually by the doctor.

Use in Children and Adolescents

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

Taking a Higher Dose of Essentiale Forte Than Recommended

There have been no reported cases of Essentiale Forte overdose.
In the event of taking a higher dose of Essentiale Forte than recommended, the below-described side effects may be intensified.

4. Possible Side Effects

Like all medications, Essentiale Forte 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 redness, rash, urticaria, itching, gastrointestinal disorders, e.g., nausea, vomiting, loose stools, diarrhea, discomfort in the abdominal cavity, increased blood pressure, palpitations, dizziness.

Reporting Side Effects

If any side effects occur, including any possible side effects not listed in this 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.
By reporting side effects, more information can be collected on the safety of the medication.

5. How to Store Essentiale Forte

The medication should be stored out of sight and reach of children.
Store in a temperature below 25°C, protect from moisture.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Essentiale Forte Contains

• The active substance of the medication is: phospholipids from soybeans containing (3-sn-phosphatidyl)choline, 1 capsule contains 300 mg.
• The excipients are: refined soybean oil, hydrogenated castor oil, hydrogenated plant-based glycerides (Witepsol W 35), triglycerides of higher fatty acids (Witepsol S 55), ethanol, ethyl vanillin, p-methoxyacetophenone, α-tocopherol.

Coating:gelatin, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate, purified water.

What Essentiale Forte Looks Like and Contents of the Pack

Yellow to brown paste of honey-like consistency in a green, opaque, elongated capsule.
The packaging contains 50, 90, 100, or 180 capsules.

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
Nattermannalee 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: June 2025