Esseliv max
Poland
Table of Contents
Package leaflet: Information for the patient
Esseliv Max
450 mg, hard capsules
Phospholipidum essentiale
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement or if your condition worsens after 3 months, you should consult your doctor.
Table of contents
- What Esseliv Max is and what it is used for
- Important information before taking Esseliv Max
- How to take Esseliv Max
- Possible side effects
- How to store Esseliv Max
- Contents of the pack and other information
1. What Esseliv Max is and what it is used for
Esseliv Max 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. Information before taking Esseliv Max
When not to take Esseliv Max
- if the patient is allergic to phospholipids from soybean seeds, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6);
- in children with body weight below 15 kg.
Esseliv Max and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or might take in the future.
No interactions between Esseliv Max and other medicines are known.
Esseliv Max with food and drink
Take this medicine during a meal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Adequate studies on the safety of 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 Max contains soybean oil, ethanol
Soybean oil
This medicine contains soybean oil. Do not use if you have been diagnosed with hypersensitivity to peanuts or soy.
Ethanol
This medicine contains 9.6 mg of alcohol (ethanol) in each hard capsule, 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 cause any noticeable effects.
3. How to take Esseliv Max
This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dosage
Take this medicine orally during a meal.
Adults and adolescents
2 capsules (900 mg) twice daily. Do not exceed 4 capsules (1800 mg) per day.
After 2-3 months of treatment, use a maintenance dose: 1 capsule (450 mg) twice daily.
Children weighing over 15 kg
In children, the dose should be 300 mg/10 kg body weight per day. On average, 1-2 capsules (450 mg–900 mg) should be administered 1-2 times daily. Do not exceed 4 capsules per day (1800 mg).
The capsule contents may be squeezed out and mixed with a small amount of warm milk or water. This method allows administration of the medicine 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 if the patient feels worse after 3 months, consult a doctor.
If you take more Esseliv Max than you should
In case of overdose, contact your doctor immediately.
There is no available data on overdose with this medicine.
If you forget to take Esseliv Max
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 effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
When used at the recommended doses, adverse effects occur infrequently.
The following adverse effects may occur:
Uncommon (occur in 1 to 10 out of 1,000 people):
- mild gastrointestinal symptoms: diarrhoea, abdominal discomfort.
Frequency not known (frequency cannot be estimated from available data):
- increased blood pressure;
- palpitations;
- dizziness;
- nausea, vomiting.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist.
Adverse effects 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 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Esseliv Max
Keep the medicine out of sight and reach of children.
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 stated month.
Lot: Batch number.
EXP: Expiry date.
Store in the original packaging, below 25°C. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the pack and other information
What Esseliv Max contains
- The active substance is soybean phospholipids. Each capsule contains 450 mg of soybean phospholipids (Phospholipidum essentiale).
- Other ingredients are: hardened fat, soybean oil, ethanol, vanillin. Composition of the hard gelatin capsule: 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 hard, brown, openable gelatin capsules filled with a thick, brown paste.
The medicine is packed in cardboard boxes containing 30 capsules or 50 capsules, together with the patient leaflet.
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