Essentiale max

Package leaflet: Information for the patient

Essentiale MAX, 600 mg, hard capsules
Phospholipidum essentiale
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 7 days, you should contact your doctor.

Contents of the leaflet

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

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

Essentiale Max is a herbal medicinal product used in liver disorders.
Indications
Relieves subjective symptoms such as loss of appetite and a feeling of pressure in the right upper abdomen caused by liver damage due to improper diet, exposure to toxic substances, or during hepatitis.

2. Important information before using Essentiale Max

When not to use 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 treatment with Essentiale Max, discuss this with your doctor or pharmacist.

• The use of Essentiale Max cannot replace the elimination from the diet of harmful substances causing liver damage (e.g. alcohol).
• In chronic hepatitis, supportive treatment with Essentiale Max is justified only if the patient experiences an improvement in general well-being during treatment.

If there is no improvement after 7 days, if symptoms worsen, new symptoms appear, or
non-specific symptoms occur, consult a 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 with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Consult your doctor before using Essentiale Max together with anticoagulant medicines.
Essentiale Max with food and drink
Take the capsules during meals, without chewing (swallow with a glass of water, for example).
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Soybeans are a common food component; so far, no harmful effects on pregnancy have been observed with their consumption. However, sufficient studies have not been conducted.
Therefore, the use of this medicine during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
Essentiale Max has no influence on the ability to drive or operate machinery.
Essentiale Max contains soybean oil, ethanol, and sodium
Due to the presence of soybean oil, this medicine may in rare cases cause severe allergic reactions. Do not use if hypersensitivity to peanuts or soy has been diagnosed.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. 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 cause noticeable effects.

3. How to use Essentiale Max

This medicine should always be used exactly as described in this patient leaflet, or as directed by your doctor. If in doubt, consult your doctor, pharmacist, or nurse.
Unless otherwise advised by your doctor, the usual dose is:
Adults and children over 12 years of age: 1 capsule three times daily.
The capsules should be taken during meals, without chewing (swallowed with, for example, a glass of water).
In general, there are no time limitations regarding the duration of treatment with Essentiale Max; however, the recommended treatment duration should be at least 1–3 months.
The treatment length may also be individually determined by the 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.
If you take more Essentiale Max than recommended
Taking more than the recommended dose may intensify the adverse effects described below.
Cases of overdose with Essentiale Max have not been reported so far.
If you miss a dose of Essentiale Max
If you miss a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Frequency unknown (frequency cannot be estimated from the available data):
an allergic reaction may occur, such as erythema, rash, urticaria, itching, gastrointestinal disturbances,
e.g. nausea, vomiting, loose stools, diarrhoea, abdominal discomfort; increased blood pressure, palpitations, dizziness.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables the collection of further information on the safety of this medicine.

5. How to store Essentiale Max

Keep this medicine out of sight and reach of children.
Store the medicine at a temperature below 25 °C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Essentiale Max contains

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

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

What the medicine looks like and contents of the pack

Yellow to brownish honey-like paste in brown, opaque, elongated hard capsules. The pack contains 30, 42 or 90 brown capsules in PVC/PVDC/Aluminium blisters, packed in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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.
Rzeszów Branch
ul. Lubelska 52
35-233 Rzeszów

For further information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00