ESSENTIALE MAX 600mg x 30 caps
ESSENTIAL MAX caps. 600 mg. * 30
PACKAGE LEAFLET: INFORMATION FOR THE USER
Essentiale Max 600 mg capsules, hard
Phospholipids from soybeans
Essentiale Max 600 mg hard capsules
Soybean phospholipids
Read all of this leaflet carefully because 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, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
If you do not feel better after 7 days 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 you take Essentiale Max
3. How to take Essentiale Max
4. Possible side effects
5. How to store Essentiale Max
6. Contents of the pack and other information
1. What Essentiale Max is and what it is used for
Your medicine for liver treatment is called Essentiale Max. Each capsule contains 600 mg of phospholipids from soybeans. Essentiale Max supplies the diseased liver with ready-made, essential (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 medicine, they are incorporated into the membranes of 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 hypochondrium, as a result of toxic or nutritional damage to the liver and hepatitis.
If symptoms do not respond to treatment, medical attention should be sought.
2. What you need to know before you take Essentiale Max
Do not take Essentiale Max if:
you are allergic to soya bean phospholipids or 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 that cause liver damage (e.g. alcohol);
Do not use in children under 12 years of age;
Due to the presence of soybean oil, this medicinal product may 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.
Essentiale Max with food, drink and alcohol
Essentiale Max is taken during meals, and the capsule should be swallowed whole, without chewing, with sufficient liquid (a glass of water).
Treatment with this medicinal product does not replace the avoidance of toxic agents that cause liver damage (e.g. alcohol).
Pregnancy, breastfeeding 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 consumed as human foods and so far there is 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 is no evidence of 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 soybeans, 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 of age (about 43 kg), adolescents and adults: 1 hard capsule (600 mg of soybean phospholipids) 3 times daily 1 hard capsule (1800 mg of soybean phospholipids)
The duration of treatment depends on the effect on subjective complaints.
Essentiale Max can be used for up to 3 months without interruption.
If symptoms do not respond to treatment, medical attention should be sought.
The capsules should be taken without chewing, during meals and with sufficient 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 information on use in children is insufficient, Essentiale Max should not be used in children under 12 years of age.
If you take more Essentiale Max than you should
There are no reports of overdose cases.
If you have taken more than the required dose, it is possible that the side effects described in section 4 may occur with greater intensity. If this happens, inform your doctor and he will assess what measures need to be taken.
If you forget to take Essentiale Max
Take Essentiale Max as recommended in point 3.
If you have not taken a capsule all day, continue taking it the next day with regular doses.
If you have any further questions on 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 assessment of each adverse drug reaction:
very common (affects 1 or more in every 10 patients);
common (affects 1 or more in every 100, but less than 1 in every 10 patients);
uncommon (affects 1 or more in every 1,000, but less than 1 in every 100 patients);
rare (affects 1 or more in every 10,000, but less than 1 in every 1,000 patients);
very rare (affects less than 1 in 10,000 patients);
not known (frequency cannot be estimated from the available data).
Sometimes the use of Essentiale Max can cause gastrointestinal disturbances such as stomach pain, soft 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 side effect and what measures need to be taken.
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting side effects
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, Tel.: +35 928903417, website: www.bda.bg. By reporting side effects, you can help to provide more information on 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 expiry date which is stated on the packaging. The expiry date refers to the last day of that month. Store below 25°C in the original packaging.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other 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: Vitepsol W35 solid fat; soybean oil; castor oil, hydrogenated; Vitepsol S55 solid fat, ethanol 96%; ethyl vanillin; 4-methoxyacetophenone, gelatin, titanium dioxide (E171), black iron oxide (E172); yellow iron oxide (E172); red iron oxide (E172); sodium lauryl sulfate; ink.
What Essentiale Max looks like and contents of the pack
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 placed on the market.
Marketing Authorisation Holder:
Sanofi-Aventis Bulgaria EOOD, Bulgaria.
Manufacturer:
A. Nattermann & Cie GmbH, Germany.
Date of last revision of the leaflet: August 2013.
