Esseliv forte

Package Leaflet: Information for the Patient

Esseliv forte, 300 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 the package leaflet for the patient or as directed by a doctor or pharmacist.

• 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 the 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.

Table of Contents of the Leaflet:

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

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

Esseliv forte contains essential phospholipids (Phospholipidum essentiale) derived from soybean seeds.
The active ingredient of phospholipids is polyenylophosphatidylcholine, which contains polyunsaturated fatty acids.
The phospholipids in the medicine are incorporated into liver cell membranes after entering the liver, which helps to supplement existing deficiencies caused by the disease and promote faster regeneration (renewal) of damaged liver cells.

Indications for Use

Acute and chronic liver diseases, including:

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

2. Important Information Before Taking Esseliv forte

When Not to Take Esseliv forte:

• if the patient is allergic to soybean phospholipids or any other ingredient of this medicine (listed in section 6).

Esseliv forte 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 forte and other medicines are known.

Esseliv forte 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 Machines

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

Esseliv forte Contains Soybean Oil

Due to the presence of soybean oil, the medicine should not be taken in case of known hypersensitivity to peanuts or soy.

3. How to Take Esseliv forte

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If there are any doubts, a doctor or pharmacist should be consulted.

Oral Medication.

Recommended Dose

The medicine should be taken orally during meals.
Adults
2 capsules (600 mg) 3 times a day. Do not take more than 6 capsules (1800 mg) per day.
After 2 to 3 months of treatment, a maintenance dose should be taken: 1 capsule (300 mg) 3 times a day.
Children
Infants should be given a dose of 300 mg per 10 kg of body weight (1 capsule per 10 kg of body weight).
Children should be given a dose of 300 mg/10 kg of body weight per day. On average, 3 to 6 capsules (900 to 1800 mg) are taken per day. Do not take more than 6 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 More Than the Recommended Dose of Esseliv forte

In case of taking more than the recommended amount of Esseliv forte, a doctor should be consulted immediately.
There are no data available on the overdose of the medicine.

Missing a Dose of Esseliv forte

A double dose should not be taken to make up for a missed dose.
If there are any further doubts about taking 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.

The Following Side Effects May Occur:

Uncommon (occurring in 1 to 10 people per 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 possible side effects not listed in the leaflet, a doctor or pharmacist should be consulted.
Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, 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

5. How to Store Esseliv forte

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

6. Contents of the Pack and Other Information

What Esseliv forte Contains

• The active substance of the medicine is soybean phospholipids. 1 capsule contains 300 mg of soybean phospholipids.
• The other ingredients are: soybean oil, hardened fat, vanillin. Ingredients of the hard gelatin capsule: gelatin, indigo carmine (E 132), iron oxide red (E 172), titanium dioxide (E 171), iron oxide yellow (E 172).

What Esseliv forte Looks Like and Contents of the Pack

Esseliv forte is a hard gelatin capsule.
The packaging of the medicine is: 30, 50, or 100 capsules packed with a patient leaflet in a cardboard box.

Marketing Authorisation 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
To obtain more detailed information, the marketing authorisation holder should be contacted.
Date of Last Revision of the Leaflet:03.10.2022