ESSELIV FORTE

Patient Information Leaflet

Esseliv forte, 300 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 leaflet or as directed
by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 months, or if you feel worse, you should contact your doctor.

Contents of the leaflet:

1. What Esseliv forte is and what it is used for
2. What you need to know 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 Esseliv forte is and what it is used for

Esseliv forte contains essential phospholipids (Phospholipidum essentiale) derived from soybean seeds.
The active component of these phospholipids is polyenylphosphatidylcholine, which contains polyunsaturated fatty acids.
After absorption, the phospholipids contained in the medicine are incorporated into the membranes of liver cells. This helps replenish existing deficiencies caused by disease and promotes faster regeneration of damaged liver cells.
Indications
Acute and chronic liver diseases, including:

• Alcohol-induced liver damage;
• Toxic and drug-induced liver damage;
• Chronic hepatitis. Supportive treatment of functional disorders of the liver and biliary tract, as well as gallstone disease.

2. Important information before taking Esseliv forte

When not to take Esseliv forte:

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

Esseliv forte and other medicines
Tell your doctor or pharmacist 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
Take the medicine during a meal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Adequate studies on the safety of using this medicine during pregnancy and breastfeeding have not been conducted.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

Esseliv forte contains soybean oil
Due to the presence of soybean oil, do not use this medicine if hypersensitivity to peanuts or soybeans has been diagnosed.

3. How to take Esseliv forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This is an oral medicine.
Recommended dose
The medicine should be taken orally during a meal.
Adults
2 capsules (600 mg) three times daily. Do not exceed 6 capsules (1800 mg) per day.
After 2 to 3 months of treatment, use the maintenance dose: 1 capsule (300 mg) three times daily.
Children
In infants, the dose is 300 mg per 10 kg body weight (1 capsule per 10 kg body weight).
In children, the dose is 300 mg/10 kg body weight per day. The average dose is 3 to 6 capsules (900 to 1800 mg) daily. Do not exceed 6 capsules per day (1800 mg).
The capsule contents may be squeezed out and administered in a small amount of warm milk or water. This allows administration 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 after 3 months, or if the patient feels worse, consult a doctor.
Taking more Esseliv forte than recommended
If more Esseliv forte has been taken than recommended, seek immediate medical advice.
There is no data available on overdose.
Missing a dose of Esseliv forte
Do not take a double dose to make up for a missed dose.
If you have any further doubts 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 everyone experiences them.
The following adverse reactions may occur:
Uncommon (occur in 1 to 10 people in 1,000):

• mild gastrointestinal symptoms: diarrhoea, abdominal discomfort.

Frequency unknown (frequency cannot be estimated from available data):

• elevated arterial pressure,
• palpitations,
• dizziness,
• nausea, vomiting.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Adverse reactions can be reported directly to:
Department for Monitoring Adverse Drug Reactions, 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

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze. Keep 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 specified month.
Markings on the blister:
Lot: Batch number.
EXP: Expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Esseliv forte contains

• The active substance is phospholipids from soybean seeds. One capsule contains 300 mg of phospholipids from soybean seeds.
• Other ingredients: soybean oil, hardened fat, vanillin. Ingredients of the hard gelatin capsule: gelatin, indigotine (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 hard gelatin capsules.
Pack sizes: 30, 50 or 100 capsules, packed with patient leaflet in a cardboard box.

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

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

For further information, please contact the Marketing Authorisation Holder.