Esseliv Max

Package Leaflet: Information for the Patient

Esseliv max

450 mg, hard capsules

Phospholipidum essentiale

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• This package 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 not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 3 months, a doctor should be consulted.

Package Leaflet Contents

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

1. What is Esseliv max and what is it used for

Esseliv max contains essential phospholipids (Phospholipidum essentiale) derived from soybean seeds.
The active phospholipid component is polyenylophosphatidylcholine, containing polyunsaturated fatty acids.
The phospholipids in the medicine, after being absorbed into the liver, are incorporated into liver cell membranes. This leads to the replenishment of existing deficiencies caused by the disease and faster regeneration (renewal) of damaged liver cells.

Indications for use

Acute and chronic liver diseases, including:

• post-alcoholic liver damage,
• toxic and drug-induced liver damage,
• chronic hepatitis. Supporting the treatment of liver function disorders, bile ducts, and gallstones.

2. Important information before taking Esseliv max

When not to take Esseliv max

• in children with a body weight below 15 kg.

Esseliv max and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions between Esseliv max and other medicines are known.

Esseliv max with food and drink

The medicine should be taken during meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
No adequate studies have been conducted on the safety of using the medicine during pregnancy and breastfeeding.

Driving and operating machinery

The medicine does not affect the ability to drive or operate machinery.

Esseliv max contains soybean oil, ethanol

Soybean oil

The medicine contains soybean oil. It should not be used in case of known hypersensitivity to peanuts or soy.

Etanol

This medicine contains 9.6 mg of alcohol (ethanol) per hard capsule, which is equivalent to 1.38% (w/w). The amount of alcohol in each hard 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 Esseliv max

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

Recommended dosage

The medicine should be taken orally during meals.
Adults and adolescents
2 capsules (900 mg) 2 times a day. Do not take more than 4 capsules (1800 mg) per day.
After 2-3 months of treatment, a maintenance dose should be used: 1 capsule (450 mg) 2 times a day.
Children with a body weight above 15 kg
Children should be given a dose of 300 mg/10 kg body weight per day. On average, 1-2 capsules (450 mg-900 mg) are given 1-2 times a day. Do not take more than 4 capsules per day (1800 mg).
The contents of the capsule can be squeezed out and given in a small amount of warm milk or water. This way, the medicine can be given to a child who cannot swallow the capsule.
Duration of treatment
The medicine should be taken for at least 3 months.
If there is no improvement or the patient feels worse after 3 months, a doctor should be consulted.

Taking a higher dose of Esseliv max than recommended

In case of taking a higher dose of Esseliv max than recommended, a doctor should be consulted immediately.
There is no data available on overdosing with the medicine.

Missing a dose of Esseliv max

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about using this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When using the recommended doses of the medicine, side effects occur infrequently.

The following side effects may occur:

Uncommon (occurring in 1 to 10 people out of 1,000):

• mild gastrointestinal symptoms: diarrhea, abdominal discomfort.

Frequency not known (frequency cannot be estimated from the available data):

• increased blood pressure;
• palpitations;
• dizziness;
• nausea, vomiting.

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, the doctor or pharmacist should be informed.
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 Esseliv max

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the blister pack and carton. The expiration date refers to the last day of the given month.
Batch: Batch number.
EXP: Expiration date.
Store in the original packaging, at a temperature below 25°C. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Esseliv max contains

• The active substance of the medicine is phospholipids from soybean seeds. 1 capsule contains 450 mg of phospholipids from soybean seeds (Phospholipidum essentiale).
• The other ingredients are: solid fat, soybean oil, ethanol, vanillin. The ingredients of the hard gelatin capsule are: titanium dioxide E 171, red iron oxide E 172, yellow iron oxide E 172, black iron oxide E 172, gelatin.

What Esseliv max looks like and contents of the pack

Esseliv max is a hard gelatin capsule, openable, brown in color, filled with a dense, brown paste.
The packaging of the medicine is: 30 capsules or 50 capsules packed with the patient package leaflet in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów

Date of last revision of the package leaflet: