ESSENTIALE MAX 600mg x 30 caps
ESSENTIALE MAX caps. 600 mg. * 30
LEAFLET: INFORMATION FOR THE USER
Essentiale Max 600 mg capsules, hard
Phospholipids from soya beans
Essentiale Max 600 mg hard capsules
Phospholipids from soybeans
Read the entire leaflet carefully as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet.
If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
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 package and additional information
1. What Essentiale Max is and what it is used for
Your liver medicine is called Essentiale Max. Each capsule contains 600 mg of phospholipids from soybeans. Essentiale Max supplies the diseased liver with ready-made, liver-basic (essential) phospholipids in high doses.
The essential phospholipids contained in this medicine correspond in chemical structure and action to the phospholipids produced in the liver of the human body. Introduced with the drug, they are embedded in the membranes of the liver cells and pass through them into the bile. Thus, Essentiale Max capsules physiologically normalize impaired liver function and the activity of its enzymes, stabilize liver membranes, which helps to regenerate liver tissue.
They affect lipid metabolism disorders by facilitating lipid transport. Stabilizes bile juice.
What is it used for
Essentiale Max is a herbal medicinal product used for liver diseases. It is used to improve subjective complaints, such as lack of appetite, a feeling of heaviness in the right lower rib, as a result of toxic or nutritional damage to the liver and hepatitis.
In case the symptoms do not respond to the treatment, medical help should be sought.
2. What you need to know before taking Essentiale Max
Do not take Essential Max if:
you are allergic to phospholipids from soybeans or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Essentiale Max.
Treatment with this medicinal product does not replace the avoidance of toxic agents causing liver damage (e.g. alcohol);
Do not apply to children under 12 years of age;
Due to the presence of soybean oil, this medicinal product can provoke severe allergic reactions.
Other medicines and Essentiale Max
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Essential Max with food, drink and alcohol
Essentiale Max is taken during meals, and the capsule must be swallowed whole, without chewing, with enough liquid (a glass of water).
Treatment with this medicinal product is not a substitute for avoiding toxic agents that cause liver damage (e.g. alcohol).
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Soybean products are widely used as human food and so far there are no data to suggest any risk during pregnancy and lactation.
The results of the studies are insufficient.
For this reason, the use of this medicinal product is not recommended during pregnancy and breastfeeding.
Driving and using machines
There are no data on the effect of Essentiale Max on the ability to drive and use machines.
Essentiale Max contains castor oil, which can cause stomach upset and diarrhea.
Essentiale Max also contains soybean oil. If you are allergic to peanuts or soy, do not use this product.
3. How to take Essentiale Max
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Age and/or body weight Single dose Maximum daily dose
For children over 12 years (about 43 kg), adolescents and adults. 1 hard capsule (600 mg phospholipids from soybeans) 3 times a day 1 hard capsule (1800 mg phospholipids from soybeans)
The duration of treatment depends on the effect on subjective complaints.
Essentiale Max can be used for up to 3 months without interruption.
In case the symptoms do not respond to the treatment, medical help should be sought.
The capsules should be taken without chewing, during meals and with enough liquid (a glass of water).
Use in children and adolescents
This medicine is intended for use in adults and children over 12 years of age. As the information on use in children is insufficient, Essentiale Max should not be used in children under 12 years of age.
If you have taken more than the required dose of Essentiale Max
No cases of overdose have been reported.
If you have taken more than the required dose, it is possible that the adverse reactions described in item 4 will manifest themselves with greater intensity. If this happens, tell your doctor and he will assess what measures need to be taken.
If you have forgotten to take Essentiale Max
Take Essentiale Max as recommended in item 3.
If you haven't taken a capsule all day, continue taking it the next day with regular doses.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Essentiale Max can cause side effects, although not everybody gets them.
The following frequencies were taken into account for the evaluation of each adverse drug reaction:
very common (affects 1 or more in 10 patients);
common (affects 1 or more in 100 but less than 1 in 10 patients);
uncommon (affects 1 or more in 1,000 but less than 1 in 100 patients);
rare (affects 1 or more in 10,000 but less than 1 in 1,000 patients);
very rare (affects less than 1 in 10,000 patients);
not known (frequency cannot be determined from the available data).
Sometimes the use of Essentiale Max can cause gastrointestinal disturbances such as stomach pain, loose stools and diarrhea. In very rare cases, allergic reactions such as exanthema (skin rash), urticaria (hives) and itching may occur.
If you experience any of the listed side effects, especially allergic reactions, stop taking Essentiale Max and inform your doctor. He will assess the severity of the adverse reactions and what measures need to be taken.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through: Executive Agency for Medicines, 8 Damyan Gruev Street, 1303 Sofia, Tel.: +35 928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Essentiale Max
Keep out of the reach of children.
Do not use Essentiale Max after the expiration date marked on the package. The expiration date corresponds to the last day of the specified month. To be stored at a temperature below 25°C in the original packaging.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What does Essentiale Max contain?
The active substance is: Phospholipids from soybeans containing 76% (3-sn-phosphatidyl) choline - 600 mg.
The other ingredients are: solid fat Vitepsol W35; soybean oil; castor oil, hydrogenated; solid fat Vitepsol S55, ethanol 96%; ethyl vanillin; 4-methoxyacetophenone, gelatin, titanium dioxide (E171), iron oxide black (E172); iron oxide, yellow (E172); iron oxide, red (E172); sodium lauryl sulfate; ink.
What Essentiale Max looks like and what is in the package
Capsules containing a brown pasty mass.
Essentiale Max is available in PVC/PVDC/aluminum blisters x 30 or 42 capsules in a clear glass bottle (type III) x 30 capsules.
Not all types of packaging can be marketed.
Marketing Authorization Holder:
Sanofi-Aventis Bulgaria EOOD, Bulgaria.
Manufacturer:
A. Nattermann & Cie GmbH, Germany.
Date of last revision of leaflet: August 2013.
